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A National Consensus Standard Process
A National Consensus Standard Process by Jane Wynn, RN
A s t a n d a r d a s referenced by the American Society of Testing and Materials (ASTM) "is a document that has been developed and established within the consensus principles of the Society and that meets the approval requirements of ASTM procedures and regulations. The term'standard' serves in ASTM as an adjective in the title of documents such as test methods or specifications, to connote specified consensus and approval. The various types of standard documents are based on the needs and usages as prescribed by the technical committees of the Society.''1 The scope of the standard writing committee #F-30 on EMS is defmed with three purposes: 1. To develop standards (classifications, guidelines, practices, specifications, terminology, and test methods) through the voluntary cooperation of those agencies, organizations, and industry groups committed to high quality EMS. 2. To stimulate research, development, maintenance and dissemination of standard disciplines, protocols, and devices involved in EMS delivery. 3. To coordinate these activities with other organizations ha~ng a mutual interest. There have been several good articles written lately with an overview of ASTM, its purpose, committee, and leadership. These articles have appeared in recent issues of Journal of Emergency
Medical Services, 2 Aeromedical Journal 3 and National Emergency Medical Technicians Newsletter.4 Therefore, we will try to explain the process utilized by the ASTM to produce a national consensus standard. The process begins at the Task Group level. The Task Group is the actual working group. At this level the standard idea, formation and writing takes place. Any interested person can be a member of a Task Group by having their name placed on the membership list. Task Group members receive copies of any information produced by that group. The ASTM, F-30, EMS Committee has 30 Task Groups with approximately 315 members. Anyone interested in EMS has the opportunity to have input into standards being written by expressing an interest in a specific Task Group. The F-30 EMS Committee received some limited funding from the National Highway Traffic Safety Administration. This funding was awarded to promote accelerated writing of some standards. As a result, there was another subset of some of the Task Groups.
Jane Wynn, RN, CEN, EMT-P, is the program director of CareFlite in Dallas, Texas, the subcommitteechairmanfor ASTM F-30.01 and the associateeditor for the AeroMedical Journal.
These subsets were small writing work groups that were funded to meet between semi-annualcommittee meetings. All of these accelerated writing groups have produced standards now being reviewed at the subcommittee level. Once a standard has been developed in the Task Group it is edited by ASTM and distributed at the subcommittee level. The subcommittee is the first formal level of voting. There are six subcommittees in the F-30 EMS committee. Voting member status begins at the subcommittee. To receive voting status you must be a member of the subcommittee. Membership is achieved by paying either a $50 individual membership fee or a $350 company fee. Once your fee is paid, you may identify which of the subcommittee(s) you want to be an active member. With this fee you are a main committee and society member. Corporations or associations with more than one member are limited to only one vote. When a standard is readied by the Task Group for voting it will come to the subcommittee members in ballot format. In order for a balloted standard to be considered valid, there must a 60 percent return of the ballots issued. This 60 percent is calculated by count-
"When a standard is readied for voting, it will come to the subcommittee members in ballot format. In order for a balloted standard to be considered valid, there must be a 60 percent return of the ballots issued." ing all affirmative, negative and abstentions returned from the voting membership. Also there must be a two-thirds approval of the voting members returning ballots. This two-thirds is calculated by combining affirmative and negatives and dividing by the number of affirmatives. Abstentions are not included in the two-thirds approval calculations. Each subcommittee member has 30 days to respond with their comments. All negative comments must be addressed by the task group. If the negative cannot be handled in the task group then it must be brought to the subcommittee meeting to be ruled either persuasive or non-persuasive by a two-thirds vote. If the negative is ruled persuasive and requires a substantive change in the document, then it would have to return to the task group to be changed and reballoted. No ballot item can move forward to the next ballot
.,~MJ JANUARY/FEBRUARY1987 21
level until all negatives and comments are handled or ruled nonpersuasive by the voting members. A negative comment is handled the same at all levels of voting from the subcommittee vote to the society vote. The task group at meeting time discusses all negatives and comments and prepares a recommendation (motion) on each for a formal hand-count vote at the subcommittee meeting. Then at the subcommittee meeting all motions to rule on negatives are acted upon by the voting members of the subcommittee present. Negative comments can be handled in five ways: 1. Withdrawn Outright by Negative Voter The task group is informed of this and merely reports this fact to the subcommittee. A negative vote may be changed to affirmative or abstention as requested by the voter. No further action required. 2. Withdrawn for Editorial Change (no change in technical content} The task group is informed of this and agrees to make an editorial change for negative withdrawal. This is reported to the subcommittee and is reflected in the meeting minutes.
3. Negative Not Related Task group recommends (motion) to rule negative not related when the voter comments do not relate to the material being balloted. This motion does not apply to misunderstanding intent of ballot item which should be ruled not persuasive.
4. Negative Ruled not Persuasive Task group recommends (motion) to rule negative vote not persuasive. A good technical reason must be given in the subcommittee in order to ask for a two-thirds hand-count approval. Failure to reach two-thirds affirmative deems the negative persuasive.
5. Negative Ruled Persuasive The task group recommends items be removed from ballot for further consideration. A revised document will be submitted for ballot prior to the next meeting. Negative votes received on subcommittee letter ballots are considered by the subcommittee that initiated the item. If consideration of a negative vote leads to substantive changes in the document (persuasive negative vote), the item must be reballoted by the subcommittee before proceeding further. If all negative votes are withdrawn or ruled not related or not persuasive, the item may go on to the main committee ballot, assuming all other ballot requirements are met. All main committee letter ballots are conducted by ASTM headquarters. Each main committee ballot item should include the following: 1. The text of the proposed item; 2. A cover letter explaining the reasons for the proposed action; 3. Tally of the subcommittee ballot; 4. Documentation on any subcommittee negative votes ruled not persuasive (reasons, vote count, and date of the not-persuasive motion and the text of the negative vote). No less than 60 percent of the members or voting interests must return ballots before a main committee ballot can close. (Abstaining votes are counted in this calculation.) To pass, the main committee ballot item must have an affirmative vote of at least 90 percent of the combined valid affirmative and negative votes cast by voting members. (Abstaining votes are not counted in the calculation.) Then, the number of affirmative, negative, and abstaining votes on each ballot item is reported to the committee by Standards Coordination at ASTM headquarters. Successful ballot items with no negative votes may be immediately submitted to society ballot by Standards Coordination. At this level, if a negative vote is submitted it is referred to the subcommittee. If the negative vote introduces reasons not significantly different from a previous consideration, the subcommittee chairman m a y recommend that the 22
JANUARY/FEBRUARY1987
AM,I
committee chairman submit the ballot item to society letter ballot. Upon successful completion of committee ballot, those items that meet all the requirements are submitted for inclusion on a society ballot published in Standardization News, the ASTM monthly magazine. Again, any negative votes on society ballot are considered by the originating subcommittee. Following successful society ballot, a ballot summary covering returns and handling of negative votes is submitted to Committee on Standards (COS}. COS determines whether procedural requireTABLE 1: Balloting Sequence & Requirements for ASTM
Standards
Level Task Groups Subcommittee
Main Committee Issued by Headquarters
Society Ballot and Public Review Committee on Standards (COS) Printer Prep, Editing PUBLICATION
% Ballot Return % Voting Negatives OFFICIAL BALLOTING NOT REQUIRED BY SOCIETY REGULATIONS: Preparation for Subcommittee ballot working draft document INTERLABORATORY TESTING 60% Voting 662/3 ALL Negatives Members BalThose Voting Affir- Considered lots (Abstain votes mative & Negative Subc. Mtg. then set aside) 2/3 to Override Not-Persuasive Same as Above 90% (~/,0) ALL Negatives Those Voting Affir- Considered mative & Negative Both Subc. and Substantiated by Main Comm. 2/3 for NotPersuasive AS'FM "Standardization News" More than voting affirmation Negatives Must be Considered by SubcJMain Comm. Final Court of Appeal for ASTM Procedural Adherance Considered Appeal-- Personal Attendance Invited Standards Dept. Interface Editorial Review Final Review by Comm./Subc. Approved ASTM Document Book of Standards & Reprints
ments have been met. Representatives of the committee and other individuals may be present and participate in discussions on controversial items. If COS approves the standards action, the document is officially published by ASTM. Table 1 graphically shows this process. Aeromedical healthcare providers should be involved in this process as they are an integral part of today's EMS picture. Areas of special interest are: 1. Task Group F-30.01.02 on Water and Air Vehicles - This group is submitting their standard for subcommittee ballot. Negative votes will be considered by the Task Group to be brought to the subcommittee meeting in May 1987 in Cincinnati, Ohio provided the above described process requirements have been met. 2. Task Group F-30.02.01on Specialty Responders - This standard was subcommittee balloted for the first round in Nashville and will be reballoted with negatives considered for the meeting in Cincinnati. This process has been chosen to develop national consensus standards in EMS. Now is the time to take advantage of an opportunity to get involved. For more specific information about the ASTM Committee F-30 contact Anne McKlindon, Staff Manager, Committee F-30 on Emergency Medical Services, ASTM Headquarters, 1916 Race Street, Philadelphia, PA 19103; 215/299-5400.~!i~ References 1. American Society of Testing Materials, Form and Style for ASTM, 7th Edition, March 1986. 2. Goldfarb, Bruce: "Constructive Antagonism, EMS Standards in the Making," Journal of Emergency Medical Services, 1117):32-34, 1986. 3. Mooney, Maureen, RN, EMT-P: "National EMS Standards, The ASTM Process," AeroMedicaIJournal, May/June 1986, pp. 24-26. 4. National Emergency Medical Technicians Newsletter published October 1986. []
A s t a n d a r d a s referenced by the American Society of Testing and Materials (ASTM) "is a document that has been developed and established within the consensus principles of the Society and that meets the approval requirements of ASTM procedures and regulations. The term'standard' serves in ASTM as an adjective in the title of documents such as test methods or specifications, to connote specified consensus and approval. The various types of standard documents are based on the needs and usages as prescribed by the technical committees of the Society.''1 The scope of the standard writing committee #F-30 on EMS is defmed with three purposes: 1. To develop standards (classifications, guidelines, practices, specifications, terminology, and test methods) through the voluntary cooperation of those agencies, organizations, and industry groups committed to high quality EMS. 2. To stimulate research, development, maintenance and dissemination of standard disciplines, protocols, and devices involved in EMS delivery. 3. To coordinate these activities with other organizations ha~ng a mutual interest. There have been several good articles written lately with an overview of ASTM, its purpose, committee, and leadership. These articles have appeared in recent issues of Journal of Emergency
Medical Services, 2 Aeromedical Journal 3 and National Emergency Medical Technicians Newsletter.4 Therefore, we will try to explain the process utilized by the ASTM to produce a national consensus standard. The process begins at the Task Group level. The Task Group is the actual working group. At this level the standard idea, formation and writing takes place. Any interested person can be a member of a Task Group by having their name placed on the membership list. Task Group members receive copies of any information produced by that group. The ASTM, F-30, EMS Committee has 30 Task Groups with approximately 315 members. Anyone interested in EMS has the opportunity to have input into standards being written by expressing an interest in a specific Task Group. The F-30 EMS Committee received some limited funding from the National Highway Traffic Safety Administration. This funding was awarded to promote accelerated writing of some standards. As a result, there was another subset of some of the Task Groups.
Jane Wynn, RN, CEN, EMT-P, is the program director of CareFlite in Dallas, Texas, the subcommitteechairmanfor ASTM F-30.01 and the associateeditor for the AeroMedical Journal.
These subsets were small writing work groups that were funded to meet between semi-annualcommittee meetings. All of these accelerated writing groups have produced standards now being reviewed at the subcommittee level. Once a standard has been developed in the Task Group it is edited by ASTM and distributed at the subcommittee level. The subcommittee is the first formal level of voting. There are six subcommittees in the F-30 EMS committee. Voting member status begins at the subcommittee. To receive voting status you must be a member of the subcommittee. Membership is achieved by paying either a $50 individual membership fee or a $350 company fee. Once your fee is paid, you may identify which of the subcommittee(s) you want to be an active member. With this fee you are a main committee and society member. Corporations or associations with more than one member are limited to only one vote. When a standard is readied by the Task Group for voting it will come to the subcommittee members in ballot format. In order for a balloted standard to be considered valid, there must a 60 percent return of the ballots issued. This 60 percent is calculated by count-
"When a standard is readied for voting, it will come to the subcommittee members in ballot format. In order for a balloted standard to be considered valid, there must be a 60 percent return of the ballots issued." ing all affirmative, negative and abstentions returned from the voting membership. Also there must be a two-thirds approval of the voting members returning ballots. This two-thirds is calculated by combining affirmative and negatives and dividing by the number of affirmatives. Abstentions are not included in the two-thirds approval calculations. Each subcommittee member has 30 days to respond with their comments. All negative comments must be addressed by the task group. If the negative cannot be handled in the task group then it must be brought to the subcommittee meeting to be ruled either persuasive or non-persuasive by a two-thirds vote. If the negative is ruled persuasive and requires a substantive change in the document, then it would have to return to the task group to be changed and reballoted. No ballot item can move forward to the next ballot
.,~MJ JANUARY/FEBRUARY1987 21
level until all negatives and comments are handled or ruled nonpersuasive by the voting members. A negative comment is handled the same at all levels of voting from the subcommittee vote to the society vote. The task group at meeting time discusses all negatives and comments and prepares a recommendation (motion) on each for a formal hand-count vote at the subcommittee meeting. Then at the subcommittee meeting all motions to rule on negatives are acted upon by the voting members of the subcommittee present. Negative comments can be handled in five ways: 1. Withdrawn Outright by Negative Voter The task group is informed of this and merely reports this fact to the subcommittee. A negative vote may be changed to affirmative or abstention as requested by the voter. No further action required. 2. Withdrawn for Editorial Change (no change in technical content} The task group is informed of this and agrees to make an editorial change for negative withdrawal. This is reported to the subcommittee and is reflected in the meeting minutes.
3. Negative Not Related Task group recommends (motion) to rule negative not related when the voter comments do not relate to the material being balloted. This motion does not apply to misunderstanding intent of ballot item which should be ruled not persuasive.
4. Negative Ruled not Persuasive Task group recommends (motion) to rule negative vote not persuasive. A good technical reason must be given in the subcommittee in order to ask for a two-thirds hand-count approval. Failure to reach two-thirds affirmative deems the negative persuasive.
5. Negative Ruled Persuasive The task group recommends items be removed from ballot for further consideration. A revised document will be submitted for ballot prior to the next meeting. Negative votes received on subcommittee letter ballots are considered by the subcommittee that initiated the item. If consideration of a negative vote leads to substantive changes in the document (persuasive negative vote), the item must be reballoted by the subcommittee before proceeding further. If all negative votes are withdrawn or ruled not related or not persuasive, the item may go on to the main committee ballot, assuming all other ballot requirements are met. All main committee letter ballots are conducted by ASTM headquarters. Each main committee ballot item should include the following: 1. The text of the proposed item; 2. A cover letter explaining the reasons for the proposed action; 3. Tally of the subcommittee ballot; 4. Documentation on any subcommittee negative votes ruled not persuasive (reasons, vote count, and date of the not-persuasive motion and the text of the negative vote). No less than 60 percent of the members or voting interests must return ballots before a main committee ballot can close. (Abstaining votes are counted in this calculation.) To pass, the main committee ballot item must have an affirmative vote of at least 90 percent of the combined valid affirmative and negative votes cast by voting members. (Abstaining votes are not counted in the calculation.) Then, the number of affirmative, negative, and abstaining votes on each ballot item is reported to the committee by Standards Coordination at ASTM headquarters. Successful ballot items with no negative votes may be immediately submitted to society ballot by Standards Coordination. At this level, if a negative vote is submitted it is referred to the subcommittee. If the negative vote introduces reasons not significantly different from a previous consideration, the subcommittee chairman m a y recommend that the 22
JANUARY/FEBRUARY1987
AM,I
committee chairman submit the ballot item to society letter ballot. Upon successful completion of committee ballot, those items that meet all the requirements are submitted for inclusion on a society ballot published in Standardization News, the ASTM monthly magazine. Again, any negative votes on society ballot are considered by the originating subcommittee. Following successful society ballot, a ballot summary covering returns and handling of negative votes is submitted to Committee on Standards (COS}. COS determines whether procedural requireTABLE 1: Balloting Sequence & Requirements for ASTM
Standards
Level Task Groups Subcommittee
Main Committee Issued by Headquarters
Society Ballot and Public Review Committee on Standards (COS) Printer Prep, Editing PUBLICATION
% Ballot Return % Voting Negatives OFFICIAL BALLOTING NOT REQUIRED BY SOCIETY REGULATIONS: Preparation for Subcommittee ballot working draft document INTERLABORATORY TESTING 60% Voting 662/3 ALL Negatives Members BalThose Voting Affir- Considered lots (Abstain votes mative & Negative Subc. Mtg. then set aside) 2/3 to Override Not-Persuasive Same as Above 90% (~/,0) ALL Negatives Those Voting Affir- Considered mative & Negative Both Subc. and Substantiated by Main Comm. 2/3 for NotPersuasive AS'FM "Standardization News" More than voting affirmation Negatives Must be Considered by SubcJMain Comm. Final Court of Appeal for ASTM Procedural Adherance Considered Appeal-- Personal Attendance Invited Standards Dept. Interface Editorial Review Final Review by Comm./Subc. Approved ASTM Document Book of Standards & Reprints
ments have been met. Representatives of the committee and other individuals may be present and participate in discussions on controversial items. If COS approves the standards action, the document is officially published by ASTM. Table 1 graphically shows this process. Aeromedical healthcare providers should be involved in this process as they are an integral part of today's EMS picture. Areas of special interest are: 1. Task Group F-30.01.02 on Water and Air Vehicles - This group is submitting their standard for subcommittee ballot. Negative votes will be considered by the Task Group to be brought to the subcommittee meeting in May 1987 in Cincinnati, Ohio provided the above described process requirements have been met. 2. Task Group F-30.02.01on Specialty Responders - This standard was subcommittee balloted for the first round in Nashville and will be reballoted with negatives considered for the meeting in Cincinnati. This process has been chosen to develop national consensus standards in EMS. Now is the time to take advantage of an opportunity to get involved. For more specific information about the ASTM Committee F-30 contact Anne McKlindon, Staff Manager, Committee F-30 on Emergency Medical Services, ASTM Headquarters, 1916 Race Street, Philadelphia, PA 19103; 215/299-5400.~!i~ References 1. American Society of Testing Materials, Form and Style for ASTM, 7th Edition, March 1986. 2. Goldfarb, Bruce: "Constructive Antagonism, EMS Standards in the Making," Journal of Emergency Medical Services, 1117):32-34, 1986. 3. Mooney, Maureen, RN, EMT-P: "National EMS Standards, The ASTM Process," AeroMedicaIJournal, May/June 1986, pp. 24-26. 4. National Emergency Medical Technicians Newsletter published October 1986. []